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AGM/DGM - Analytical Development Biotechnology

9.00 to 14.00 Years   Bangalore   17 Dec, 2021
Prescription Pharma Support Pvt Ltd
Job LocationBangalore
EducationNot Mentioned
SalaryNot Disclosed
IndustryManagement Consulting / Strategy
Functional AreaGeneral / Other Software
EmploymentTypeFull-time

Job Description

Opening for the leading Bio-pharmaceutical company in India.Job DescriptionPosition Title: Assistant General Manager/Deputy General Manager - Analytical Development Biotechnology.Function: Physicochemical Qualification and ExperienceMasters or PhD degree in Biochemistry, Cell Biology, Analytical Chemistry or related scientific/technical backgroundA minimum of 10-12 years of experience in the biotechnology/pharmaceutical industry, including a minimum of 3-4 years experience involving quality control laboratories in a facility making bio-pharmaceutical drug substance and/or drug product for US and/or EU studies. Must have at least 5-6 years supervisory or managerial experienceRole Purpose- The incumbent will be responsible for defining and managing the analytical development, method transfer and quality control functions in support of in-process, release and stability testing of drug substance and drug product for early-stage bio-pharmaceutical development programs- will provide oversight and participate in the management and monitoring of cGMP-compliant contracted manufacturing and product and stability testing activities- and will work with quality assurance, compliance and regulatory functions to meet project demands and contribute to submissions to regulatory authorities.Knowledge and skills

  • Thorough knowledge of biochemistry, bioassay and associated instrumentation; knowledge of protein stability assessment
  • Experience in validation and transfer of methods used for characterization of biological products
  • Experience in handling LC-MS, MS-MS, MALDI-TOF etc. is desirable
  • Experience in validation and transfer of methods used for characterization of biological products
  • Working knowledge of current Good Manufacturing Practices (cGMPs) for the US and EU, Good Laboratory Practices (GLPs), and ICH guidelines as they relate to testing and characterization efforts for late phase clinical and commercial drug supply and/or biopharmaceutical production
  • Ability to prioritize and successfully manage complex and competing projects
  • Excellent communication and organizational skills
  • Ability to proactively mitigate quality/regulatory risks
  • Motivated team player with proven leadership abilities
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Keyskills :
continuous improvement facilitationcell biologyquality controlmethod transferquality assurancestability testinganalytical chemistryanalytical developmentichcelllcmssupplytestingbiologycontrolclinicalchemistryassuranceoversight

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